TheranosticTrials.org

Clinical Trial · NCT07217717

Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Pancreatic Ductal Adenocarcinoma (PDAC)

Overview

This is a multi-site, open-label, non-randomized, single dose study to assess the clinical utility of \[¹⁸F\]FAPI-74 PET/CT in the detection of metastatic disease in individuals with pathologically confirmed pancreatic ductal adenocarcinoma. Following screening, using a standardized administration protocol and dose, participants will undergo \[¹⁸F\]FAPI-74 PET/CT screening. SOC procedures and interventions will be captured during 3 months +/-14 days post injection. The primary objective is to evaluate the sensitivity and specificity of such \[¹⁸F\]FAPI-74 PET/CT using a composite SOT panel. The maximum expected duration of the trial is approximately 24 months from first patient screening to last patient SOC follow up. The participants will be followed-up for safety for 24 to 72 hours after the dose of \[¹⁸F\]FAPI-74 PET/CT.

Sponsor

SOFIE

Phase

Phase 3

Contacts

Bridget Adams (CONTACT)

bridget.adams@sofie.com

1-800-753-5368

Sherly Mosessian, Ph.D (STUDY_DIRECTOR)

Alex Osipova (CONTACT)

alex.osipova@sofie.com

1-800-753-5368

ClinicalTrials.gov

NCT07217717

Drug / Compound

FAPI-74

Isotope(s):
Target(s):
  • FAP
Ligand Class: Small Molecules
Chelator: DOTA

Eligibility

Inclusion

  • Provided signed, written informed consent obtained prior to any study-related procedures.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2:
  • Participants with confirmed PDAC, undergoing staging evaluation for treatment planning.
  • * Male and female adults ≥ 18 years.
  • Participants are required to have a ceCT scan of chest, abdomen and pelvis as per standard clinical practice and practice guidelines either 21 days or less prior to entry or planned within 21 days of \[¹⁸F\]FAPI-74 administration.

Exclusion

  • Previous cancer diagnosis (except basal cell carcinoma of the skin or in situ carcinoma of the cervix/uterus). Participants treated with curative intent and disease-free for more than 5 years are permitted.
  • Prior administration of a radiopharmaceutical within 10 half-lives of that product from the time of \[¹⁸F\]FAPI-74 administration.
  • Known hypersensitivity to \[¹⁸F\]FAPI-74.
  • Administration of another investigational therapeutic or diagnostic product within 30 days prior to \[¹⁸F\]FAPI-74 administration.
  • * Unequivocal evidence of metastases at the time of enrollment that would preclude surgery as a treatment option.